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Filgrastim

Phase 2

HIV Infections | Small molecule | Infectious Disease |Amgen Inc.|Last Updated: Mar 7, 2014

Target and mechanism

ModalitySmall molecule

Also known as Injection of Filgrastim, of Filgrastim

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

Filgrastim · 4 trials · 4 indications

Phase 2 2Phase 1 2
NCT00114764Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)Myeloid Leukemia
COMPLETED84 Analytics
NCT00002126A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.HIV Infections
COMPLETED250 Analytics
PHASE2COMPLETED
Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
Myeloid LeukemiaUnlock trial analytics
PHASE2COMPLETED
A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
Induction cycle 1
feasibility of administering study therapy to limit skin toxicity
4 weeks
dose-limiting toxicity
4 weeks

Secondary Endpoints

Duration of severe neutropenia during induction chemotherapy
Induction cycle 1
response
14 weeks
time to progression
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
pegfilgrastimEXPERIMENTALPegfilgrastim given once after induction chemotherapy
filgrastimACTIVE_COMPARATORFilgrastim given daily after induction chemotherapy

Interventions

NameTypeDescription
filgrastimDRUGFilgrastim given daily after induction chemotherapy
pegfilgrastimDRUGPegfilgrastim given once after induction chemotherapy
PaclitaxelDRUG1-hour IV infusion once weekly for 12 to 14 weeks
VinorelbineDRUGescalating doses administered intravenously over 6-10 minutes for 12-14 weeks
RadiationRADIATIONRadiotherapy for 5 consecutive days every other week (weeks 1, 3, 5, 7, 9, 11, 13)starting on same day as first dose of protocol chemotherapy
Epoetin alfaDRUG -
ZidovudineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion * Histologically confirmed de novo AML as evidenced by absence of an antecedent hematologic disease of \> 1 months duration, prior chemotherapy, prior radiation therapy or myelodysplastic cytogenetics (as per exclusion criteria) * Life expectancy, with treatment, \> 3 months * Age \> 18 y...

Countries:United StatesCanada
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